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NCT01594398 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

A Phase 1 study of Breast Cancer and Lung Cancer, sponsored by Syndax Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
3
Study locations

NCT01594398 is a Phase 1 study of Breast Cancer and Lung Cancer that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 14 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT01594398, a Phase 1 study of Breast Cancer and Lung Cancer, has completed, sponsored by Syndax Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®) or erlotinib (Tarceva®). A biomarker (chemical "marker" in the blood/tissue that may be related to your response to the study drug) will also be tested.

Conditions Studied

Breast Cancer Lung Cancer Non-small Cell Lung Cancer (NSCLC) Estrogen Receptor Breast Cancer

Interventions

  • DRUG Exemestane
  • DRUG Erlotinib
  • DRUG entinostat

Study Locations (3)

Florida

  • Florida Cancer Specialists - Sarasota

Oklahoma

  • Peggy and Charles Stephenson Cancer Center - Oklahoma City

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-05
Est. Completion 2014-05
Phase Phase 1

Sponsor

Syndax Pharmaceuticals

25 total trials

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What the Registry Record Tells You About NCT01594398

The ClinicalTrials.gov registry entry for NCT01594398 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Syndax Pharmaceuticals, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Exemestane is the first listed.

NCT01594398 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Oklahoma, Tennessee.

Frequently Asked Questions

What is clinical trial NCT01594398 about?

NCT01594398 is a clinical study titled "Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer". The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by i...

What is the current status of trial NCT01594398?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-05. Estimated completion is 2014-05.

What conditions does trial NCT01594398 study?

This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Non-small Cell Lung Cancer (NSCLC), Estrogen Receptor Breast Cancer.

What interventions are being tested in trial NCT01594398?

The interventions under investigation include: Exemestane (DRUG), Erlotinib (DRUG), entinostat (DRUG).

Who is sponsoring clinical trial NCT01594398?

This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01594398 being conducted?

This trial has 3 study locations across Florida, Oklahoma, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.